Pharmaceutical Quality Systems: A Risk-Based Perspective
Overview
This one-day, in-person course at NIBRT Dublin provides participants with a comprehensive understanding of Pharmaceutical Quality Systems, their key elements, and how they are applied in practice from a risk-based perspective.
Through real-world examples and practical exercises, attendees will gain insight into how a well-implemented PQS supports product quality, regulatory compliance, and continuous improvement, as well as how risk management informs decision-making, process design, and compliance across the product lifecycle.
A robust Pharmaceutical Quality System (PQS) is essential to ensure consistent production of safe, effective, and high-quality medicines. It forms the foundation of compliance with Good Manufacturing Practice (GMP) and regulatory expectations across the pharmaceutical and biopharmaceutical industries.
Key topics covered
- Introduction to Pharmaceutical Quality Systems
- Quality System Elements
- Roles and Responsibilities within a PQS
- Deviation, CAPA, and Change Management Processes
- Quality Risk Management and Continuous Improvement
- Practical Workshops and Case Studies
Who should attend
This course is suitable for manufacturing, quality, and technical personnel working in the biopharmaceutical industry who wish to deepen their understanding of Pharmaceutical Quality Systems. It is particularly beneficial for individuals looking to strengthen their knowledge of how PQS principles are applied in daily operations.
What do Attendees Obtain on Completion?
All participants will receive a Certificate of Attendance upon completion of the course.
Register
Course Format
Onsite Training at NIBRT
- 1 full day onsite training at NIBRT facility
Dates & Price
Dates:
- Course 1 20/04/2026€995.00
12 Places Remaining
